You face complex regulations increasing compliance costs and slowing product launches. Rapid tech advancements require ongoing innovation while meeting regulatory standards, making traditional development models obsolete. With agilityIRL, you gain a partner born from the med device industry that has “cracked the code” for accelerating software development in med tech. We help you: • Streamline your QMS, cutting outdated practices while aligning with FDA, saving time and easing compliance. • Build Design History Files incrementally, reducing last-minute stress for smoother, faster releases. • Boost team execution with our Agile Regulatory training (CARS™) combined with training and coaching, making processes agile and compliant. • Cultivate a culture for seamless transformation, empowering confident, swift, and sustainable innovation.